Effect of Negative-Pressure Drainage Versus Pancreatic Duct Stenting for Preventing Pancreatitis After Endoscopic Papillectomy for Duodenal Papillary Tumors

Официальное название

Effect of Negative-Pressure Drainage Versus Pancreatic Duct Stenting for Preventing Pancreatitis After Endoscopic Papillectomy for Duodenal Papillary Tumors: A Prospective, Multicenter, Randomized Controlled Trial

Обзор

This prospective, multicenter, randomized controlled trial aims to evaluate the effectiveness of negative-pressure duodenal drainage compared with prophylactic pancreatic duct stenting in preventing post-endoscopic papillectomy (EP) pancreatitis. Eligible patients undergoing EP will be randomized 1:1 to receive either negative-pressure drainage or pancreatic duct stenting. The primary outcome is the incidence of post-EP pancreatitis. Secondary outcomes include other procedure-related complications, procedure time, technical success, length of hospital stay, hospitalization cost, en-bloc and R0 resection rates, and postoperative hyperamylasemia.

Подробное описание

This study is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate two postoperative drainage strategies following endoscopic papillectomy (EP). Patients scheduled for EP for duodenal papillary neoplasms will be screened according to predefined inclusion and exclusion criteria. After providing written informed consent, eligible participants will be randomized in a 1:1 ratio to the negative-pressure drainage group or the pancreatic duct stent group.

All participants will undergo standardized EP performed by experienced endoscopists. According to group assignment, either a nasally inserted negative-pressure drainage tube or a prophylactic pancreatic duct stent will be placed intraoperatively. Postoperative management includes intravenous fluids and nutritional support, fasting for the first 48 hours, and routine medications to prevent infection, pancreatitis, and bleeding. Diet will be gradually resumed based on clinical and imaging assessments.

Throughout hospitalization, key clinical outcomes will be recorded, including the incidence of post-EP pancreatitis, other procedure-related complications, procedure time, technical success, length of hospital stay, total hospitalization cost, resection quality (en-bloc and R0 resection rates), and postoperative hyperamylasemia. All participants will undergo inpatient postoperative monitoring and a scheduled 1-month follow-up visit to collect clinical status, laboratory results, and device-related information.

The study team will perform statistical analyses based on follow-up data to compare the efficacy and safety of the two drainage strategies. The findings are expected to clarify the clinical value of negative-pressure duodenal drainage and provide evidence to guide optimization of postoperative management after endoscopic papillectomy.

Вмешательства

• Устройство Placement of a negative pressure drainage tube
  A flexible polymer drainage tube is inserted transnasally immediately after endoscopic papillectomy and advanced so that the tip rests distal to the papilla in the descending duodenum. The external end is connected to a manual suction device to provide continuous negative pressure and promote evacuation of pancreatic secretions and duodenal contents. The tube is monitored for function, displacement, and blockage and is removed approximately 72 hours postprocedure if no significant complications
• Процедура Placement of a pancreatic duct stent
  A plastic pancreatic duct stent is placed under endoscopic and fluoroscopic guidance immediately after endoscopic papillectomy to facilitate pancreatic drainage and reduce the risk of postoperative pancreatitis. Stent diameter and length are selected by the endoscopist based on intraoperative findings and preoperative imaging. If stent placement fails after three or more attempts or cumulative placement time exceeds 15 minutes, the procedure is considered unsuccessful and a nasally inserted nega

Первичные конечные точки

• Incidence of post-endoscopic papillectomy pancreatitis [Срок оценки: Postoperative days 1, 2, and 3 (assessed daily); from postoperative day 4 through hospital discharge from the index hospitalization, assessed as clinically indicated (when pancreatitis is suspected)]

Вторичные конечные точки (8)

• R0 resection rate (complete resection) [Срок оценки: At final pathology assessment (upon pathology report issuance; typically within 7 days after endoscopic papillectomy）]
• Technical success rate of intended drainage placement [Срок оценки: During the endoscopic papillectomy procedure (Day 0), assessed immediately after attempted completion of the assigned drainage method]
• Incidence of hyperamylasemia [Срок оценки: 6 hours, 24 hours, and 48 hours after endoscopic papillectomy.]
• Length of hospital stay [Срок оценки: From admission to hospital discharge (up to 7 days)]
• En bloc resection rate [Срок оценки: Immediately after lesion resection during the endoscopic papillectomy procedure (Day 0)]
• Incidence of postoperative complications [Срок оценки: From completion of endoscopic papillectomy (Day 0) through postoperative day 30 (±7 days).]
• Duration of endoscopic papillectomy (EP) [Срок оценки: During the endoscopic papillectomy procedure (Day 0), recorded immediately after procedure completion]
• Total hospitalization cost [Срок оценки: From admission to hospital discharge (up to 7 days)]

Критерии участия

Критерии включения

• Age between 18 and 75 years
• Preoperative diagnosis of duodenal papillary adenoma or early-stage adenocarcinoma (≤T1a)
• Scheduled to undergo endoscopic papillectomy

Критерии исключения

• Preoperative diagnosis suggestive of adenocarcinoma ≥T1b stage.
• Preoperative imaging indicating intraductal extension into the pancreatic or bile duct ≥20 mm.
• Lesion diameter >40 mm, location adjacent to a duodenal diverticulum, or other anatomical or technical factors deemed unsuitable for endoscopic resection.
• Known familial adenomatous polyposis (FAP).
• Severe cardiopulmonary disease precluding tolerance of anesthesia or endoscopic procedures.
• Coagulopathy or bleeding disorders.
• Pregnancy or lactation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07446543 · NYSZYYEC2025K110R002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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